TRIPS: ISSUES

TRIPS and public health

The WTO Doha Declaration on the TRIPS Agreement and Public Health, agreed by WTO members in 2001, helped to frame the health policy context of the intellectual property system. It stressed the need for the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) to be part of the wider national and international action to address public health problems afflicting developing countries and least-developed countries. The Declaration identified specific options open for governments to address public health needs, also termed ‘flexibilities’, and the importance of such flexibilities was highlighted more recently by their inclusion in the Sustainable Development Goals.

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Compulsory licences for export of medicines

The flexibilities identified in the Doha Declaration include “the right to grant compulsory licences”.  A compulsory license is issued by a government authority or a court to make certain use of a patented invention without the consent of the patent holder. This mechanism is generally present in most patent laws, is recognized as a permissible option or flexibility under the TRIPS Agreement, and has been used by a number of WTO members in the pharmaceutical field. However, TRIPS rules originally restricted compulsory licences to serve mainly the domestic market, unless they were issued to deal with anti-competitive behaviour.

The Doha Declaration recognized that this restriction on compulsory licensing could hamper its effective use by countries with insufficient or no manufacturing capacities in the pharmaceutical sector. The amendment of the TRIPS Agreement aims at removing this difficulty by creating an additional form of compulsory licence that had not existed before: a compulsory licence especially tailored for the export of medicines to countries in need – in effect, a 'trade related' compulsory licence. This mechanism was sometimes termed the 'paragraph 6 system', from its origins in the Doha Declaration.

The new Article 31bis of the TRIPS Agreement gives full legal effect to this system and allows low cost generic medicines to be produced and exported under a compulsory licence exclusively for the purpose of serving the needs of countries that cannot manufacture those products themselves.  For the minority of WTO members yet to accept the amendment, an interim waiver will continue to apply.

 

Amendment to the TRIPS Agreement

News item on entry into force of the amendment.

Video statements: some of the key players share their thoughts on the entry into force of the amendment.

Factsheet on the TRIPS amendment

Text of the 2005 decision amending the TRIPS Agreement

Amendment of the TRIPS Agreement: How many members have accepted the amendment?

How to accept the protocol amending the TRIPS Agreement: Background information for members on procedures

 

Implementing compulsory licences for export of medicines

Special compulsory licences for export of medicines: key features of WTO Members' implementing legislation: Staff Working Paper

National implementation legislation: countries implementing the system in their laws

Guide to Notifications

 

Background information

Extract on special compulsory licences from the WHO-WIPO-WTO Study, “Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade

Frequently asked questions: compulsory licensing of pharmaceuticals and TRIPS

TRIPS Council annual reports on the paragraph 6 system

 

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